Medina Covers the C-144-01 Study: Lifileucel in Advanced Melanoma
Theresa Medina, MD, discusses the C-144-01 study of lifileucel in patients with advanced melanoma.
Theresa Medina, MD, associate professor of medicine-medical oncology at the University of Colorado Cancer Center, Anschutz Medical Campus, discusses the C-144-01 study (NCT02360579) of lifileucel (Amtagvi) in patients with advanced melanoma and data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
In the phase 2, registrational, open-label, multicenter, multicohort, C-144-01 trial, patients treated with lifileucel had an objective response rate (ORR) of 31.4%, as assessed by an independent review committee. These findings come from a 5-year follow-up of the C-144-01 trial that assessed the long-term efficacy and safety of lifileucel.
“That response seemed to be durable and maintained through the 5-year survival or the 5-year follow-up. In addition, we saw that with the 5-year analysis, there were not any late or new adverse events that occurred for the patients that received the lifileucel therapy,” says Medina.
A total of 79.3% of patients had tumor burden reduction, and 16 had deepened responses with 4 converting from partial response to complete response > 1 year after lifileucel infusion. Further, 31.3% of patients who responded completed the 5-year assessment with ongoing responses.
The median duration of response was 36.5 months. Among responders (n = 48), there was lower tumor burden and fewer liver or brain metastases compared with the overall population. Additional findings showed that the median overall survival (OS) was 13.9 months, with a 5-year OS of 19.7%.
“Then the most important finding was the overall survival benefit that was seen at 5 years; about 20% of patients, 19.7% of the patients, were still alive at 5 years, which, in this patient population, is a significant finding, given that they had very limited treatment options,” Medina says.
Regarding safety, adverse events were consistent with nonmyeloablative lymphodepletion and interleukin-2 safety profiles and declined rapidly within 2 weeks after lifileucel infusion. The majority of grade 3 or 4 cytopenias resolved to grade ≤ 2 by day 30.
“All of the adverse events that occurred developed in the time period after infusion and typically resolved within 2 weeks after that infusion,” adds Medina.
